E-health and People Living With Major Neurocognitive Disorder - CARE© and ESOGER© Applications

NCT05571553 | Completed

• 1 other identifier: 2023-1625
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The care pathways of people living with major neurocognitive disorders (MNCD) are often inadequate due to poor access to resources, long delays, and resources that are poorly adapted to expectations and needs. This situation was exacerbated during the coronavirus disease (COVID-19) pandemic due to the reduction of available resources and care provider burnout. People living with MNCD are at risk of becoming more fragile, which can lead to emergency room visits and hospitalizations, and significantly alter the quality of life of the dyad (family caregiver and the person being cared for). Intervening earlier in the care pathway would make it possible to avoid the aggravation of pathologies associated with MNCD and hospitalizations. The reorganization of activities imposed by the social distancing measures due to the pandemic has shown that e-health is a solution to maintain access to resources for people living with chronic conditions such as MNCD. We have been working since the beginning of the pandemic on the development of two complementary health applications for seniors and their dyads: the self-assessment questionnaire on frailty (CARE©) and the Evaluation et orientation SOcio-GÉRiatrique (ESOGER©) questionnaire :

• CARE© is made by the dyad, allowing to identify a state of frailty and the risks related to it. It relies on the active participation of the user and is deployed in the form of an application.
• ESOGER© is a standardized hetero-questionnaire filled out remotely, during a telephone call, by a community organization worker with the user and/or his/her caregiver. It is a tool for first contact, listening and accompanying a user, which makes it possible to determine whether the needs for care and services are being met, to prioritize the needs, to trigger the implementation of care and services, and to make the link with the organizations providing care and services. The objectives of this study are to examine the effects of CARE© combined with ESOGER© on the state of physical and mental frailty, loss of autonomy, quality of life, and consumption of health services and care resources in people living with a major neurocognitive disorder (MNCD).

Conditions

Major Neurocognitive Disorder; Frailty

Keywords

E-Health

Outcome Measures

Primary Outcomes (2)

• CARE© Score

  Measure of frailty via a standardized self-questionnaire consisting of 22 simple questions. The CARE© score ranges from 0 (no deficits) to 21 (maximum cumulative deficits). This score has been segmented into 3 levels according to a validated approach in order to determine 3 levels of frailty which are : * The robust level: score between 0 and 1. * The pre-fragile level: score between 2 and 4. * The fragile level: score \> 5. For phase 1 : evaluated at M0 and M3, and the variation between M0 and M3. For phase 2 : evaluated at M0, M3 and M6, and the variation between the three periods.

  8 months

• Response Rate to CARE© questionnaires

  Response Rate to CARE© questionnaires and the time required to complete the questionnaires. For phase 1 only.

  4 months

Secondary Outcomes (10)

• BGA Score

  8 months

• COVID-19 symptoms

  8 months

• Psychological stress

  8 months

• Social Isolation

  8 months

• Caregiver burden

  8 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Phase 1 * Participants will assess their health status, at home, at recruitment (M0) and at 3 months (M3) with CARE© with the help of their family caregivers. * The principal investigator or a representative will contact them by phone within 5 days of the CARE© assessment to complete ESOGER. Phase 2 * Participants will assess their health status, at home, at recruitment (M0), at 3 months (M3), and at 6 months (M6) on the CARE© application with the help of their family caregivers. An additional assessment will take place over the phone by the principal investigator or one of his representatives. * If their health status is considered fragile, then individuals will be contacted by phone by the PI or one of his representatives to complete the ESOGER© questionnaire (at M0, M3 and M6).

Other: Recommendations and reorientation towards healthcare resources

Control group

NO INTERVENTION

Phase 1 * Participants will assess their health status, by telephone, at recruitment (M0) and at 3 months (M3) with CARE© with the help of their family caregivers. * The principal investigator or a representative will contact them by phone within 5 days of the CARE© assessment to complete ESOGER. Phase 2 * Participants will assess their health status, at home, at recruitment (M0), at 3 months (M3), and at 6 months (M6) on the CARE© application with the help of their family caregivers. An additional assessment will take place over the phone by the principal investigator or one of his representatives. * If their health status is considered fragile, then individuals will be contacted by phone by the PI or one of his representatives to complete the ESOGER© questionnaire (at M0, M3 and M6).

Interventions

Recommendations and reorientation towards healthcare resources OTHER

Phase 1 * After completing the CARE© questionnaire, participants will be given recommendations. * After the ESOGER© assessment, the participants will be contacted by the Red Cross who will set up the necessary interventions. They will be informed of the results of the assessments made. Phase 2 * After completing the CARE© questionnaire, participants will be given recommendations. * If their health status is judged fragile by the CARE© score, and after the ESOGER© assessment, the participants will be contacted by the Red Cross who will set up the necessary interventions. They will be informed of the results of the assessments. For both phases, after 3 (6) months, the participants of the Control group will benefit from the recommendations following the CARE© assessment done at M3 (M6), and if necessary from the ESOGER© assessment and the Red Cross intervention. Throughout the study, they will continue to receive their conventional care.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Be 65 years old or older.
• Have been previously diagnosed of MNCD (major neurocognitive disorder).
• Have a caregiver.
• Live in Montreal.
• Live at home or in a residence for seniors (RPA) in a non-medicalized area.
• Have an internet connection.
• Have a computer, or a touch pad or a smart phone.
• Understand French or English orally and in writing. The speakers are French and/or English speaking, and the questionnaires are only available in these 2 languages.

You may not qualify if:

• Participate in a concurrent investigational clinical study, to avoid interference with our study
• Live in a Residential and Long-Term Care Center (CHSDL) or in a medical sector in an RPA

Sponsors & Collaborators

• Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal: lead

Study Sites (1)

CRIUGM

Montreal, Quebec, H3W 1W5, Canada

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Senior researcher, Director of laboratory

Model Details: Phase 1 This is an experimental study of the randomized, longitudinal, prospective clinical trial type with a 3-month follow-up, open, in parallel groups (intervention versus control), carried out in people living with an MNCD and their family caregivers. Number of participants : 120 Phase 2 This is a randomized, longitudinal, prospective, clinical trial with a 6-month follow-up, open, in parallel groups (intervention versus control), carried out in people living with an MNCD. The total number of participants needed will be re-evaluated following analysis of the results obtained in Phase 1. We estimate at this time that a total of 40 participants per group, for a total of 80 people, is the number of participants needed for this study

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: December 1, 2022
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)